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Beyond post-marketing research and MedWatch: Long-term studies of drug risks

机译:超越上市后研究和MedWatch:长期研究 毒品风险

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摘要

Critics of the drug safety system have discussed many different potential reforms, ranging from mandatory registration of clinical trials to increasing the power of regulatory agencies, but few have discussed one of the most important ways of enhancing safety: increasing the number of long-term studies of medications. Long-term studies of the risks and benefits of drugs can provide useful information for regulators, healthcare professionals, and patients. Government funding agencies should lead the effort to conduct long-term studies of drugs, but private companies should also be required to lend financial support. Because cost-effectiveness is likely to be an important consideration in conducting this research, funding agencies should focus, at first, on drugs that are used to treat common, chronic conditions.
机译:药品安全体系的批评者讨论了许多不同的潜在改革,从强制性临床试验注册到增加监管机构的能力,但很少有人讨论提高安全性的最重要方法之一:增加长期研究的数量药物。对药物风险和益处的长期研究可以为监管机构,医疗保健专业人员和患者提供有用的信息。政府资助机构应领导对毒品进行长期研究的努力,但也应要求私营公司提供财务支持。由于成本效益可能是进行这项研究的重要考虑因素,因此资助机构首先应将重点放在用于治疗常见的慢性病的药物上。

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